FOI release

Freedom of Information request on the establishment of groups and sub-groups examining information relating to the IMMDS Review (FOI 21-580)

Published 13 August 2021

25th June 2021 FOI 21/580

Dear

Thank you of your email of 27th May 2021 where you requested follow up information in response to a reply to FOI - 21/448 CSC 47559 providing the groups and sub groups comprising of experts, patients and /or both, that have been set up in relation to and/or to examine information relating to

a) IMMDS Review, b) IMMDS Recommendations, c) the safety of Sodium Valproate in pregnancy and d) the updating of contraindications of sodium Valproate:

I) Patient Safety & Engagement Committee

II) Delivery & Performance Committee

III) IMMDS Review Co-Ordination Group

IV) Sodium Valproate Expert Working Group

V) Pharmacovigilance Expert Advisory Group

VI) Neurology/Pain and Psychiatry Expert Advisory Group

VII) Valproate Stakeholder Network

In this FOI 21/580, you ask if any of the above group/representatives will

1) Be liaising with each other on the topic of Sodium Valproate and/or Sodium Valproate in pregnancy

2) Be liaising with other groups set up by the MHRA and/or the Dept of Health on Sodium Valproate and/or Sodium Valproate in pregnancy

We would like to clarify that the Delivery and Performance Committee and the IMMDS Review Co-ordination Group are part of the internal governance of the Agency and they are both comprised only of internal members of staff, with no external experts or patients. The Patient Safety and 2 Engagement Committee (PSEC) is a new sub-committee which reports to the Board. Both the Agency Board and PSEC have considered the Agency’s plans for responding to the recommendations of the Independent Medicines and Medical Devices Safety Review, including those relating to valproate.

The Pharmacovigilance Expert Advisory Group and the Neurology/Pain and Psychiatry Expert Advisory Group both report to the Commission on Human Medicines (CHM) which is the Government’s independent expert advisory committee on the quality, safety and efficacy of medicines. The Sodium Valproate Expert Working Group is an ad hoc working group which reports to the CHM. The Secretariat for the CHM and its expert groups is provided by the MHRA.

A dedicated team at MHRA assesses the safety of valproate and seeks advice as necessary on changes to the product licence from the Sodium Valproate Expert Working Group, Pharmacovigilance Expert Advisory Group and Neurology/Pain and Psychiatry Expert Advisory Group who make recommendations to CHM. The same team supports the Valproate Stakeholder Network and represents MHRA on the National Health Service England/Improvement (NHSE/I) Valproate Safety Implementation Group (VSIG) to share information with partner organisations on the various activities related to safe use of valproate and improving the implementation of the pregnancy prevention programme for valproate. MHRA assessors liaise on a regular basis with members of the wider department on the work of the VISG.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Please remember to quote the reference number above in any future communications.

If you are not content with the outcome of the internal review, you have the right to apply directly to the Information Commissioner for a decision.

The Information Commissioner can be contacted at: Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF If you have a query about this letter, please contact me.

Yours sincerely,

FOI Team, Vigilance and Risk Management of Medicines Division